SSI Strategy

Adam Schwartz, President, SSI Strategy

SSI Strategy is a boutique management consulting firm that is well regarded in the pharmaceutical industry for its expertise in supporting the needs of the medical affairs, pharmacovigilance, and clinical development functions within life science companies. The company’s vision is to help elevate the medical/scientific functions within Life Science companies and support strategic leaders, by driving organizational strategy to ensure that the science, medical needs of patients, and the healthcare community are considered throughout drug development. “We focus on serving the medical/scientific functions typically centralized within the Office of the Chief Medical Officer – and supporting the leaders of these functions to establish a “Strategic CMO’ office that drives value for patients and other stakeholders,” affirms, Adam Schwartz, President of the company.

SSI was founded with the premise that leaders within the Medical/Scientific functions, including drug safety and pharmacovigilance were missing a strategic level of independent support that could not be provided through the array of services provided by contracted research/safety organizations. SSI aimed to support clients through leadership, advisory, and more discreet projects that help to establish core aspects of the Medical/Scientific functions. Their aim is to ensure best in class strategy, operations, and compliance in the safety department- maintaining in all aspects of the PV system. The delivery model brings together Drug Safety and Pharmacovigilance subject matter expertise (former Heads of Safety, Safety Scientists, and Safety Operations Leads) with the discipline of consulting professionals to deliver as an integrated team. “In this way, we bring together the expertise as well as the operational rigor to each of our engagements, delivering meaningful impact and results for our clients”, says Adam. The team often serves as an insourcing of PV roles to further bolster departmental responsibilities and drive progress at critical points of a company/product’s lifecycle.

Since its inception in 2010, SSI has grown from a small team of safety professionals to a team of diverse life science subject matter experts with experience in various disciplines and leadership positions, such as Chief Medical Officers, and Heads of Safety, Heads of Clinical Development, and Medical Affairs Leaders. The company has expanded into areas such as inspection readiness, post-merger integration, and PV Medical leadership within its Safety practice. It also holistically supports the Chief Medical Officers (CMO) and the functions that fall within the CMO’s purview, including Clinical Development, Clinical Operations, Medical Affairs, Medical Operations & Excellence, Health Economics, and Outcomes Research (HEOR), and Real World Evidence.

Distinguished Services

SSI’s team builds and supports safety functions at all stages of the product lifecycle from early input in study design to post-marketing requirements, signaling, and trending. The team has extensive experience in safety strategy, operations, systems evaluation, remediation, and post-merger integration of the safety system/function.

With the unique blend of safety experts and experienced business consultants, the company brings together the expertise and experience needed to excel in the safety space as well as operational rigor to implement key regulatory requirements.

The most notable and differentiating factor in SSI Strategy is its range of select service offerings. The services include Interim Safety Process Improvement, PV/Safety Post Merger Integration, PV Vendor Sourcing and Management, Inspection Preparation, and Remediation.

Customer-centric Approach & Innovative Mindset

“As a company, we continue to grow in terms of team members but also experience and expertise across novel therapies. We currently are supporting clients in cell and gene therapy, digital therapeutics, and other novel areas where the role and needs around drug safety are being further defined,” says Adam. SSI has been working with clients to navigate these new areas as well as helping them to establish the necessary strategy and infrastructure to ensure patient safety. 

The team at SSI focuses on understanding the unique goals, strategies, and challenges for each unique product portfolio and pipeline. It customizes the approach to the client’s specific situation and culture- acting as an extension of their team. “We approach every engagement collaboratively and help our client team members build new capabilities while growing their knowledge and experience base. We believe this is how we can establish and build long-lasting relationships with our clients,” shares Adam.

Footsteps towards Future

SSI continues to grow both organically and inorganically. Recently, the company has received a growth investment from Amulet Capital Partners, a middle-market private equity firm focused exclusively on the healthcare sector. With Amulet’s investment, the first institutional funding taken by SSI, the firm plans to accelerate the growth of its team and drive the expansion of strategic services to support Medical, Safety, Clinical, and other critical path functions at the C-level of Life Sciences companies.

The company aims to continue to grow its team and capabilities to support more clients in PV/Safety. To catalyze this growth, SSI has recently acquired Fiore Healthcare Advisors, a leading PV/Safety consulting firm. With this acquisition, it is onboarding an experienced PV team and client array to help the company continue to support clients with their PV needs and expand into new areas of support. 

“Lastly, we also have established a Gene Therapy Accelerator to enable the rapid expansion of early-stage companies through the combination of direct investment and our industry-leading consulting capabilities. We continue to seek out partners and investment opportunities in this space,” concludes, Adam.

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